Takeda plans German plant to support dengue vaccine roll-out

Will
invest more than €100m in the Singen manufacturing facility

Takeda is investing more than €100m in a manufacturing facility in Germany that will produce its vaccine for dengue fever.

The plant in Singen is a "major step towards meeting important unmet needs in dengue prevention," according to the Japanese drugmaker, which recently started a phase III trial of its TAK-003 dengue vaccine candidate.

Initial construction activities will start immediately, and the facility should be ready for production in 2019, Takeda said.

"Our colleagues in Singen have vast experience in lyophilisation technology, which is key for the manufacturing process of Takeda's dengue vaccine finished product," said Thomas Wozniewski, who heads up global manufacturing and supply at Takeda.

Dengue is the fastest spreading mosquito-borne viral disease and 40% of the world's population lives under the threat of the virus, according to the World Health Organization (WHO).

The disease infects 390 million people a year and symptoms include fever, a hammering headache, flu-like symptoms, bone, muscle and joint pain, rash and nausea and vomiting.

While most patients recover, the disease poses a considerable economic burden on society - it is estimated to cost India upwards of $500m a year for example - and causes around 20,000 deaths a year worldwide.

There is already one dengue vaccine on the market - Sanofi's Dengvaxia - but this is rolling out more slowly than expected due to political and economic problems in Latin America and a delay to its approval in India after the country declined to waive the requirement to conduct clinical trials in an Indian population.

Sanofi's setbacks have trimmed its lead over Takeda and other dengue vaccines in development, including a candidate from the US National Institutes of Health (NIH) that is also in phase III testing.

Takeda started its phase III TIDES trial of the live-attenuated TAK-003 vaccine in September, seeing whether the candidate can protect subjects against symptomatic dengue fever caused by any of the four dengue virus serotypes, regardless of age and whether the individual has previously been exposed to the virus.

Pre-exposure to dengue is a point of debate at the moment, as some research suggests second dengue infections tend to be far more severe. A study recently suggested Dengvaxia might act like a first natural infection, so if a patient is exposed a second time to the virus they can suffer more severe illness. If confirmed, it could raise questions about using the vaccine in areas where dengue is less prevalent.

Takeda's trial intends to address that from the off. The trial will enrol 20,000 people aged between four and 16 in countries where dengue is endemic, focusing on Latin America and Asia.